Received Apr 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 3 | — | IM |
he has runny/itchy nose; he has runny/itchy nose; ringing in the ears; pins and needles in legs, face and head; The customer stated that he has had brain problems going on for a whole year; he had some "breathing problems"/he still has breathing problems; he has swallowing problems which began in 2024; This spontaneous case was reported by a patient and describes the occurrence of CEREBRAL DISORDER (The customer stated that he has had brain problems going on for a whole year), DYSPNOEA (he had some "breathing problems"/he still has breathing problems), DYSPHAGIA (he has swallowing problems which began in 2024), NASAL PRURITUS (he has runny/itchy nose) and RHINORRHOEA (he has runny/itchy nose) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2024, the patient experienced DYSPNOEA (he had some "breathing problems"/he still has breathing problems) and DYSPHAGIA (he has swallowing problems which began in 2024). On an unknown date, the patient experienced CEREBRAL DISORDER (The customer stated that he has had brain problems going on for a whole year), NASAL PRURITUS (he has runny/itchy nose), RHINORRHOEA (he has runny/itchy nose), TINNITUS (ringing in the ears) and PARAESTHESIA (pins and needles in legs, face and head). At the time of the report, CEREBRAL DISORDER (The customer stated that he has had brain problems going on for a whole year), DYSPHAGIA (he has swallowing problems which began in 2024), NASAL PRURITUS (he has runny/itchy nose), RHINORRHOEA (he has runny/itchy nose), TINNITUS (ringing in the ears) and PARAESTHESIA (pins and needles in legs, face and head) outcome was unknown and DYSPNOEA (he had some "breathing problems"/he still has breathing problems) had not resolved. No concomitant medications were reported. It was reported that the patient had received three covid-19 vaccines in 2021. Patient haven't received any other covid vaccines. Patient reported that he had some breathing problems in 2024 but, he also mentioned it could be due to mold in his apartment. Patient reported he had heard that the vaccines cause blood clots, heart problems and stroke. Patient reported that he had difficulty to understand at times. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2025: Live follow up received contains no new information. On 14-Apr-2025: Live follow-up received contains significant information and added new event of Difficulty breathing, swallowing difficult, Nasal itching, Runny nose, Pins and needles, ringing in ears, reporter details added, Patient demographics added, suspect dosing regimen added, narrative updated, and reference ID added.; Reporter's Comments: Exposure to mold could be a contributor for the event Dyspnoea. The benefit-risk relationship of the product is not affected by this report.